II Workshop on Positron Emitting Radiopharmaceuticals and Molecular Imaging – São Paulo, 2014

GMP EU Guidelines

COMMISSION DIRECTIVE 2003/94/EC (2003) GMP guidelines medicinal
products for human use and investigational medicinal products for human use
GMP Medicinal Products for Human and Veterinary Use Explanatory Notes on the preparation of a Site Master File (v. 4, 2010) download

Medicinal Products for Human and Veterinary Use, Manufacture of Radiopharmaceuticals (v. 4, annex 3, 2008)

Manufacture of investigational medicinal products (v. 4, annex 13, 2003) download

Aulas Prof. Bert Windhorst

Qualification and validation (2001) download
Basics of cyclotron radioisotopes production download
Design and development of radiopharmaceuticals download
Design of a dossier for human applications of new radiopharmaceuticals download
F-18 choline investigational medicinal production dossier (IMPD, 2012) download
Radiochemistry of carbon‐11 , nitrogen‐13 and oxygen‐15 download
Radiochemistry of fluorine‐18 and iodine‐123/124 download
Radiopharmaceutical and radioisotopes regulatory issues in Europe download
Nuclear Medicine & PET Research VUMC (2006) download

S. Vallabhajosula, Molecular Imaging: Radiopharmaceuticals for PET and SPECT, Springer-Verlag Berlin Heidelberg 2009

Capítulo 5, Production of Radionuclides download
Capítulo 10, Chemistry of Radiohalogens (F, Br. and I) download
Capítulo 11, Chemistry of Organic Radionuclides (C, N, and O) download